Generic Name: Glucose Monitoring System — Brand Name: Dexcom G7 Cgm System
- Recalling firm
- Name of Manufacturer/Distributor: DexCom Japan LLC — Address of Manufacturer/Distributor: 7th Floor, Arco Tower, 1-8-1 Shimomeguro, Meguro-ku, Tokyo — Type of License: Class I Medical Device...
- Product
- Lot: 対象となる製品： Dexcom G7 CGM システム モニター 製造記号： PG423G07FE00003604 PG423G07FE00004266 PG423G07FE00004277 PG423G07FE00012165 PG423G07FE00012191 PG423G07FE00012211 PG423G07FE00012218 PG423G07FE00012221 PG423G07FE00012222 PG423G07FE00012230 PG423G07FE00012232 PG423G07FE00012234 PG423G07FE00012235 PG423G07FE00012337 PG423G07FE00012387 PG423G07FE00012390 PG423G07FE00012391 PG423G07FE00012393 PG423G07FE00012394 PG423G07FE00012397 PG423G07FE00012399 PG423G07FE00012400 PG423G07FE00012401 PG423G07FE00012403 PG423G07FE00012409 PG423G07FE00012497 PG423G07FE00012498 PG423G07FE00012502 PG423G07FE00012506...
- Reason
- Following an investigation into customer complaints by the overseas manufacturer, it was determined that the speakers on certain G7 monitors with specific serial numbers may fail to produce sound; therefore, we are conducting a voluntary recall. Although there are multiple suppliers of the speakers installed in the G7 Monitor, it was discovered that a component (urethane foam reinforcement) in the speakers supplied by one of these suppliers was defective. As a result, the urethane foam may lose its resilience over time, potentially causing poor contact between the speaker and the...
- Classification
- Class II
- Category
- medical device recall
- Country
- Japan
- Agency
- PMDA-DEVICE
- Status
- Ongoing
Official recall notice from PMDA-DEVICE
Recall details on Nibble Recalls: https://trynibble.app/recalls/9725600c-5e56-47e3-a542-641112112729